Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot Feasibility Study
1 other identifier
observational
40
1 country
1
Brief Summary
This study generates information on the feasibility and acceptability of a 3-month ecological momentary assessment (EMA) protocol to assess chronic pain and opioid use in adolescent and young adult (AYA) sarcoma survivors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedStudy Start
First participant enrolled
March 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
April 15, 2026
April 1, 2026
10 months
January 28, 2026
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (7)
Feasibility of recruitment
Feasibility of recruitment will be based on number eligible per medical record
Up to 12 months
Feasibility of assessment
will be indexed by number completing 80% of EMA assessments
Up to 12 months
Feasibility of recruitment
will be indexed by number attending baseline interview
up to 12 months
Feasibility of recruitment
will be indexed by retention throughout EMA period
Up to 12 months
Reasons for nonparticipation
Semi structured qualitive interviews will focus on factors that influenced participation
UP to 12 months
Acceptability of EMA Study Design
self-reported difficulty of participating in daily EMA surveys (0-19) .
Up to 12 months
Acceptability of EMA Design
Acceptability of the protocol will be assessed by responses on the System Usability Scale - A 10 question scale from 1 to 5 with 1 being strongly disagree and 5 being strongly agree.
Up to 12 months
Interventions
Non intervention study
Eligibility Criteria
Patients younger than 70 years old who were diagnosed with sarcoma between the ages of 12-24 and have no evidence of disease and/or are enrolled in survivorship care.
You may qualify if:
- All genders between the ages of 12-24 (inclusive) at sarcoma diagnosis.
- Any age \< 70 at the time of study enrollment.
- No evidence of disease and/or enrolled in survivorship care.
- Clinically meaningful pain related to disease or its treatments at baseline (defined as 3 or greater on a 0-10 Numerical Rating Scale).
- Willing to attend the baseline appointment in person.
- Access to internet-capable smartphone.
- Access to internet on an occasional basis.
- Willing and able to complete Ecological Momentary Assessments (EMAs) on internet-capable smartphone for a 3-month period after enrollment.
- Ability to understand and provide informed consent/assent.
You may not qualify if:
- \* Currently receiving active cancer-directed therapy.
- Unable to read or fluently speak English.
- Determined by clinical staff to have preexisting or cancer-associated cognitive impairment that could interfere with study participation.
- Acutely suicidal (e.g. intent or plan) or, with unstable medical or psychiatric condition verified by licensed study staff.
- Characteristics related to inability to complete the study protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roswell Park Cancer Institutelead
- University at Buffalocollaborator
Study Sites (1)
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Rogers
Roswell Park
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 11, 2026
Study Start
March 30, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2028
Last Updated
April 15, 2026
Record last verified: 2026-04